Trials / Completed
CompletedNCT01899911
Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)
Pulse Oximeter Response TO Multiple Levels Of Stable Hypoxia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- LifeWatch Services, Inc. · Industry
- Sex
- All
- Age
- 23 Years – 33 Years
- Healthy volunteers
- Accepted
Summary
A clinical study designed to determine the accuracy of the peripheral capillary oxygen saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood saturation level.
Detailed description
The clinical study protocol was designed for determining the accuracy of the SpO2 function of the Vital Signs Patch device for measuring blood oxygen saturation level, according to the guidelines for "evaluating and documenting SpO2 accuracy in human subjects" as set out in Annex EE of ISO 80601-2-61. Section 4.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vital Signs Patch (VSP) | Infrared and red absorbance measurement |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2013-07-16
- Last updated
- 2015-08-28
- Results posted
- 2015-08-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01899911. Inclusion in this directory is not an endorsement.